Protective Effect of Thymosin α1 Against Negative Immune Dysregulation and Organ Dysfunction After Acute Aortic Dissection Surgery (PANDA II) (PANDA)

Systemic inflammatory response syndrome (SIRS) and multiple organ dysfunction syndrome (MODS) are the major causes of death in patients with acute aortic syndrome (AAS). Therefore, the prevention of SIRS and MODS is of great clinical value, and immunomodulatory therapy with thymosin alpha 1 may be beneficial. This study was designed to test the hypothesis that the administration of thymosin alpha 1 during the acute phase of AAS will result in a reduced incidence of SIRS and MODS.

Study Overview

• Status: Completed
• Conditions: Acute Aortic Syndrome; Aortic Dissection Type A
• Intervention / Treatment: Drug: Thymosin Alpha1, 28A-Glycine-28B-L-Arginine-28C-L-Glutamic Acid-28D-L-Alanine-28E-L-Proline-28F-L-Alanine-28G-L-Asparagine-; Drug: Blank control

• Study Type: Interventional
• Enrollment (Actual): 600
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing, China, 10029
    • Beijing Anzhen Hospital Capital Medical University
  • Guangzhou, China
    • The First Affiliated Hospital of Guangzhou Medical University
  • Nanchang, China
    • The Second Affiliated Hospital of Nanchang University
  • Shanghai, China
    • Shanghai East Hospital Tongji University
  • Tianjin, China
    • Teda International Cardiovascular Hospital
  • Anhui
    • Bengbu, Anhui, China
      • the First Affiliated Hospital of Bengbu Medical College
  • Guangdong
    • Guangzhou, Guangdong, China
      • Guangdong Provincial People's Hospital
  • Jiangsu
    • Nanjing, Jiangsu, China, 210029
      • The First Affiliated Hospital of Nanjing Medical University
    • Nanjing, Jiangsu, China
      • Nanjing First Hospital Nanjing Medical University
    • Yangzhou, Jiangsu, China
      • Subei People's Hospital of Jiangsu province
  • Shandong
    • Jinan, Shandong, China
      • Qilu Hospital of Shandong University
  • Sichuan
    • Chengdu, Sichuan, China
      • West China Hospital of Sichuan University
  • Xinjiang
    • Kazak, Xinjiang, China
      • The Friendship Hospital of Yili Kazak Autonomous Prefecture
    • Ürümqi, Xinjiang, China
      • The Seventh Affiliated Hospital of Xinjiang Medical University
  • Yunnan
    • Kunming, Yunnan, China
      • The First Affiliated Hospital of Kunming Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 86 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• The patients are conformed to 2010 ACC/AHA guidelines for the diagnosis and treatment of thoracic aortic disease (TAD) within two weeks of onset;
• Patients with acute aortic syndrome confirmed clinically and radiologically and planning to undergo emergency surgery were enrolled.
• The patients' age between 18 ~90 years old.
• Agree to participate in the study and sign the informed consent.

Exclusion Criteria:

• Patients allergic to Thymosin α1;
• Lactating women and pregnant women;
• Patients with mental diseases, drug and alcohol dependence;
• Refuse to participate in this study and refuse to sign the informed consent.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Thymosin alpha 1; 1.6 mg q12h for 5 days	Drug: Thymosin Alpha1, 28A-Glycine-28B-L-Arginine-28C-L-Glutamic Acid-28D-L-Alanine-28E-L-Proline-28F-L-Alanine-28G-L-Asparagine-; Thymosin alpha 1, 1.6mg injection hypodermic (I.H), every 12 hours for 5 days at least during the ICU admission. The administration will be terminated any day during the treatment when the patient is deemed as qualified for ICU discharge or dead.
Other: Blank control; Standard care control; no placebo or sham thymosin alpha 1 injections were administered.	Drug: Blank control; Blank control (Standard care control; no placebo or sham thymosin alpha 1 injections were administered.)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
7-day postoperative organ dysfunction burden assessed by mean daily SOFA score	The primary outcome is early postoperative organ dysfunction burden, quantified as the mean daily Sequential Organ Failure Assessment (SOFA) score over postoperative days 1-7 using a fixed 7-day assessment window. Higher scores indicate greater organ dys	7 days after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
30-day mortality	Death from any cause of 30 days after randomization	30 days after randomization

Collaborators and Investigators

• Sponsor: Nanjing Medical University
• Collaborators: West China Hospital; Qilu Hospital of Shandong University; Nanjing First Hospital, Nanjing Medical University; Guangdong Provincial People's Hospital; Beijing Anzhen Hospital; The First Affiliated Hospital of Guangzhou Medical University; Second Affiliated Hospital of Nanchang University; TEDA International Cardiovascular Hospital; First Affiliated Hospital of Kunming Medical University; Shanghai East Hospital of Tongji University; Northern Jiangsu People's Hospital; The First Affiliated Hospital of Bengbu Medical University; The Seventh Affiliated Hospital of Xinjiang Medical University
• Investigators: Principal Investigator: Hong Liu, Nanjing Medical University

Publications and helpful links

General Publications

• Liu H, Qian SC, Zhang YY, Tang CB, Yue HH, Fan GL, Zhao X, Jiang YY, Huang FH, Zeng ZH, Wang W, Lu XR, Luo XK, Bai XF, Zheng XX, Xie P, Ma C, Zhao S, Zhang HJ; On the behalf of China Additive Anti-inflammatory Actions for Aortopathy and Arteriopathy (5A) and PANDA Trial Investigators. Effect of thymosin alpha1 on Immune response and organ function in acute aortic dissection surgery: PANDA II trial protocol. Future Cardiol. 2025 Jun;21(7):447-454. doi: 10.1080/14796678.2025.2505401. Epub 2025 May 14.

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2022
• Primary Completion (Actual): March 31, 2025
• Study Completion (Actual): July 31, 2026

Study Registration Dates

• First Submitted: April 15, 2022
• First Submitted That Met QC Criteria: April 15, 2022
• First Posted (Actual): April 21, 2022

Study Record Updates

• Last Update Posted (Actual): September 14, 2026
• Last Update Submitted That Met QC Criteria: September 9, 2026
• Last Verified: September 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Aortic Diseases; Acute Aortic Syndrome; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptide Hormones; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Thymosin; Thymus Hormones; Thymalfasin
• Other Study ID Numbers: PANDA II

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No